Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration
研究概览
简要总结
Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. Stored blood undergoes some changes that may make it less effective in achieving this goal. The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to children undergoing heart surgery.
Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this study is considered investigational. This is a pilot study and data will be collected for future protocol development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime)
- •children undergoing cardiac surgery with cardiopulmonary bypass
排除标准
- •refusal of blood products
- •end-stage renal disease
- •planned avoidance of CPB
- •use of non- heparin anticoagulants
- •participation in an experimental drug or device protocol within 30 days
- •existing hemoglobinopathy
- •allergy requiring washed RBCs
- •immunocompromise requiring special blood product treatment.
研究组 & 干预措施
Rejuvenated PRBCs
The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).
干预措施: Rejuvesol (Drug)
Rejuvenated PRBCs
The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).
干预措施: Cardiac surgery (Procedure)
结局指标
主要结局
Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration
时间窗: End of Surgery
Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)
时间窗: 2 hours
Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels
时间窗: end of bypass
次要结局
未报告次要终点
